Breathing mask with a sealing lip device

ABSTRACT

A mask to administer breathable gas to a user may include a body structure having a connection opening to connect to a line device to deliver the breathable gas; a sealing lip device to seal against the user&#39;s face, the sealing lip device joined to the body structure, and the sealing lip device having an upper bridge portion structured to cross the bridge of the user&#39;s nose in use, a pair of side portions structured to be positioned along corresponding side surfaces of the user&#39;s nose in use, and a lower bridge portion structured to cross the user&#39;s upper lip or chin region in use; and a pair of beadlike gel cushions, each positioned in a corresponding one of the side portions.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/177,586, filed Feb. 11, 2014, which is a continuation of U.S. patentapplication Ser. No. 11/988,503, filed Jan. 9, 2008, which is a NationalStage entry of PCT/EP2006/007121, filed Jul. 19, 2006, which claims thebenefit of German Patent Application Nos. 10 2005 033 648.5 and 10 2005033 650.7, each filed Jul. 19, 2005, the entire contents of each ofwhich is incorporated by reference in this application.

BACKGROUND OF THE INVENTION

The invention is directed to a breathing mask device, a sealing lipdevice for a breathing mask device, as well as to a molding tool and amethod for producing a corresponding breathing mask device and sealinglip device.

Breathing mask arrangements are used particularly for administering abreathable gas mixture, such as ambient air, at a pressure level that isabove ambient pressure. Delivering the breathing gas at a pressure levelabove the ambient pressure can be used for instance for performingso-called CPAP therapy for treating stroke- or sleep-related respiratorydisturbances.

From International Patent Application PCT/EP02/11798, incorporatedherein by reference in its entirety and filed by the present Applicant,a breathing mask device for administering a breathable gas to a user isknown. This breathing mask device makes it possible, in cooperation withthe face area of a user of the mask, to seal off a mask interior of thebreathing mask from the environment. Such breathing masks are usedparticularly in conjunction with medical or therapeutic administrationof breathable gases, as well as in the industrial field, for instance inthe field of gas masks and breathing equipment. Typically in thesebreathing masks, the sealing off from the face area of the breathingmask user is achieved using a sealing lip structure that extends,oriented inward, around an opening in the mask and is seated on the facearea and is made from an elastically deformable material. The sealingaction achieved with such sealing lips generally increases with thecontact pressure of the sealing lip against the face area. In the caseof high contact pressures, long-term use of such breathing masks inparticular can be unpleasant. A need in the art has developed to addressthis problem.

BRIEF SUMMARY OF THE INVENTION

An aspect of the invention is to provide ways that make it possible tocreate a breathing mask device which while being sufficiently nonleakingis distinguished by being especially comfortable to wear and moreovercan be produced advantageously in times of industrial production.

According to one embodiment or example of the invention, there isprovided a breathing mask device for administering a breathable gas,having a body structure, which in the application position is pressedwith a sufficient retention force against a contact surface of a user'sface, a sealing lip device that in cooperation with the body structureand the portion of the user's face defines a breathing mask interior andseals it off from the environment, a gel structure for at leastintermittent and partial transmission of the retention forces, acting onthe body structure, to the user's face area, and a gel material definingthe gel structure is received in a gel receiving chamber defined atleast in part by an elastically deformable receiving wall. The elastomermaterial intended for forming the receiving wall is integrally formed(e.g., overmolded, co-molded) onto a wall portion of the breathing maskdevice, and is lifted or separable from this wall portion to form thegel receiving chamber.

As a result, it becomes advantageously possible to create a breathingmask device that includes a gel structure that is especially effectivewith a view to an advantageous transmission of the mask forces. The gelstructure can be formed by introducing the gel material into a gelreceiving chamber, defined at least in some portions by an elastomerwall, for furnishing the gel receiving chamber. The elastomer wall islifted or separable from a portion of the breathing mask device thatfunctions as a mold wall in the context of the injection of theelastomer material.

In an embodiment of the invention, the gel receiving chamber is embodiedsuch that it functions as a bracing bead portion. The bracing beadportion is preferably embodied such that it extends between the bodystructure of the breathing mask device and a user's face sealing lip ofthe breathing mask device. The bracing bead portion may be embodied suchthat it extends over the entire circumference of the sealing lip device.Preferably, however, the bracing bead portion is embodied in segmentedfashion, such that it extends only in the contact region of the user'sface sealing lip laterally bordering the nose. In the region of thesealing lip device that crosses the bridge of the nose as well as theupper lip region (in the case of a nose mask) or the chin region(full-face mask), embodying the gel structure can be dispensed with. Asan alternative to completely dispensing completely with the gelstructure in the aforementioned portions, it is also possible to embodythe gel structure as recessed, in such a way that in the region of thebridge of the nose and in the upper lip or chin region, it transmits nobracing forces, or at least not any major or substantial bracing forces.

In an embodiment of the invention, the user's face sealing lip isembodied integrally with the wall that forms the receiving wall of thegel structure. Binding the user's face sealing lip to the remainingregion of the sealing lip device may be accomplished in such a way thatexcessively high contact pressures resulting from the intrinsic rigidityof the user's face sealing lip or of the peripheral structure providedfor binding the user's face sealing lip are generated. This mechanicalbehavior can be attained, e.g., by using suitably low Shore hardnessesand by suitably adapting the wall thicknesses and the three-dimensionalcurvature of the user's face sealing lip.

In an embodiment of the invention, the body structure is embodied as aso-called hard mask shell. The hard mask shell may be made from acompletely transparent thermoplastic plastic material (e.g.,polycarbonate). The hard mask shell may have connection structures(e.g., an inlet or elbow) for connecting a breathing gas line,particularly in the form of a flexible hose. The hard mask shell mayalso include gas washout devices that enable an adequate washout of usedbreathing gas out of the breathing mask interior to the environment.

In an embodiment of the invention, the sealing lip device isinjection-molded onto this hard mask shell. Before the injection-moldingof the sealing lip device onto it, the hard mask shell is preferablytreated in such a way that it has locally demarcated reactive zones thatare capable of adhesion, so that in these reactive zones the injectedmaterial bonds with high-strength adhesion to the body structure. Thesereactive zones may in particular be brought about by a corona or plasmatreatment of the appropriate or selected regions of the hard mask shell.Alternatively to this, or in combination with this provision, it is alsopossible to create these locally demarcated reactive zones by applyingadhesion promoters or by some other suitable treatment of the hard maskshell. The material comprising the hard mask shell, the type of zonesintended for embodying an adhesive bond, and the properties of theelastomer material injection-molded onto the hard mask shell arepreferably adapted such that the effect sought of a sufficiently heavyduty local bond between the elastomer material and the material of thehard mask shell is attained. The regions in which an excessively strongadhesion of the injected elastomer material to the hard mask shell isnot wanted may optionally be locally suitably shielded by theapplication of parting means or a template or mask.

In an embodiment of the invention, in the region in which the elastomerwall for later embodying the gel receiving structure, the hard maskshell is defined such that by means of the hard mask shell, anadvantageous fundamental geometry of this elastomer wall is alreadyassured. In particular, the applicable portion of material can beinjection-molded onto a bulging wall portion of the hard mask shell.Once the applicable elastomer material portion has been lifted from thebulging wall portion of the hard mask shell, a suitably large receivingchamber for the gel material is then created by cupping. The gelmaterial may be introduced with a certain overpressure into the gelmaterial receiving chamber intended for receiving the gel material andcan in the process widen the elastomer wall. The geometry of theelastomer wall is preferably adapted such that at the latest in thewidened state of the elastomer wall, the desired geometry of the gelstructure is attained.

It is possible to provide filling conduits or fill valve structures onthe sealing lip device or preferably in particular on the hard maskshell, by way of which conduits or structures of the gel receivingchamber intended for receiving the gel material can be filled. It ispossible directly by means of the introduction of the gel material tolift or separate the wall, locally suitably injection-molded first ontothe hard mask shell, by means of the gel material, so that the gelreceiving chamber is accordingly generated gradually (blown up orexpanded) in the course of the introduction of the gel. Thisintroduction of the gel material can be done even before the completeunmolding of the mask device.

Another aspect of the invention is directed to a sealing lip device fora breathing mask with a gel structure having a gel body and an elastomerjacket surrounding the gel body in at least some portions; in thecontext of an injection-molding operation, the jacket is formed byinjection molding of the elastomer material onto an opposite wall, andjacket is lifted or separated from this opposite wall in the course ofthe introduction of the gel material. The opposite wall forms part of ahard mask shell made from a substantially rigid plastic material. Theopposite wall may also be furnished by means of an elastomer structureformed in the context of a preceding injection step.

Another aspect of the invention is further directed to a method forproducing a breathing mask device. According to the method, insuccessive production steps, a breathing mask device is formed thatincludes a body structure and a sealing lip device. The sealing lipdevice is formed by injection of an elastomer material in portions ontothe body structure in a mold chamber of a molding tool. The bodystructure is prepared, in a method step that may precede the elastomermaterial injection step, such that adhesion zones are created, in whichthe elastomer material (later) injected onto the hard shell enters intoan adhesive bond with the body structure. The injection is also done insuch a way that detachment zones are created, in which the injectionelastomer material can be lifted from the body structure.

Another aspect of the invention is directed to a method for producing abreathing mask device having a body structure and a sealing lip device,wherein the method comprises forming at least one adhesion zone on thebody structure, injection-molding the sealing lip device with anelastomer material onto the body structure in a suitable mold chamber,forming an adhesive bond between the body structure and the sealing lipdevice in each adhesion zone; and creating detachment zones in which theinjected elastomer material of one or more portions of the sealing lipdevice is detachable from the body structure.

The adhesion zones, in an embodiment of the method, are generated bycorona or plasma treatment. This corona or plasma treatment is performedin particular, after only partial unmolding of a molding tool intendedto form the hard mask shell, by introducing a mask device into themolding tool and performing a locally defined and selective treatment of(only) certain portions of the hard mask shell. As an alternative toplasma or the corona treatment or in combination with this provision, itis also possible to treat the hard mask shell locally with suitableadhesion promoters.

The detachment zones, that is, the zones in which the elastomer materialcan be detached quite easily from the hard shell, are preferably alreadygenerated by the basic properties of the material provided for formingthe hard shell. If needed, however, it is possible, in the vicinity ofthe corresponding adhesion zones, to shield or mask the regions of thehard shell that will later function as detachment zones, in such a waythat the elastomer material injected onto them will not enter into anexcessively strong adhesive bond with the hard mask shell. In thisrespect it is possible in particular to generate the detachment zones bythe application of parting means (a shield, mask or template). Applyingthe parting means can be done using shielding baffles, by means of sprayapplication, or by printing, in particular screen printing.

Lifting or separating the elastomer material injection-molded onto thedetachment zones preferably forms a receiving chamber, into which acushioning filling is introduced. This cushioning filling may be formedby a gas, in particular easily compressed ambient air; a foam material;or as mentioned several times above, a viscous material, in particularsilicone gel.

According to another embodiment of the invention, there is provided amulti-part molding tool for forming a mask including a body portion anda sealing lip device, comprising a first mold segment; a second moldsegment adapted to be positioned with respect to the first mold segmentto form a first mold cavity having a first portion with a shape thatmatches a first portion of the body portion; a third mold segmentadapted to be positioned with respect to the first and second moldsegments to further define a second portion of the first mold cavitythat has a shape that matches a second portion of the body portion; anda fourth mold segment to replace the third mold segment, the fourth moldsegment being arranged with respect to the first and second moldsegments and the then-formed body portion to define a second mold cavityhaving a shape matching a first portion of the sealing lip device.

These and other aspects of the invention will be described in orotherwise apparent from the following detailed description ofembodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

Further details and characteristics of the invention will becomeapparent from the ensuing description in conjunction with the drawings.Shown are:

FIG. 1, a sectional sketch explaining the makeup of a breathing maskdevice according to an embodiment of the invention, in the region of thesealing lip device thereof;

FIG. 2A, a sketch for explaining a hard shell component of the breathingmask device of FIG. 1;

FIGS. 2B-1 to 2B-3, a perspective sketch illustrating the portions, usedas adhesion zones, of the hard shell element of FIG. 2A;

FIG. 3, a cross-sectional sketch illustrating the production of thebreathing mask device of an embodiment of the invention, in a stateimmediately after the injection-molding of the elastomer material,intended to form the sealing lip device, onto the hard shell element;

FIG. 4, a sketch illustrating a filling portion for filling the hardmask shell with the gel material according to an embodiment of thepresent invention;

FIG. 5, a cross-sectional sketch explaining a preferred makeup of a hardshell element for furnishing large enough injection-molded wall portionsaccording to an embodiment of the present invention;

FIG. 6, a further cross-sectional sketch explaining details of thegeneration according to an embodiment of the invention of the gelstructure;

FIG. 7A, a basic sketch explaining the employment of the concept of anembodiment of the invention in the pairing of hard and elastomermaterials;

FIG. 7B, a sketch explaining the concept of an embodiment of theinvention in pairing of elastomer/elastomer materials;

FIG. 8, a perspective sketch illustrating a breathing mask deviceaccording to an embodiment of the invention that includes a bodystructure, e.g., a hard shell element, and an elastomer sealing lipdevice injection-molded onto it, in which the sealing lip device incooperation with the body structure forms two finger-like receivingchamber portions, into which a gel material is introduced, forming gelbead portions;

FIG. 9A, a basic sketch illustrating relatively large-area detachmentzones according to an embodiment of the present invention;

FIG. 9B, a basic sketch illustrating a breathing mask sealing lipaccording to an embodiment of the present invention;

FIG. 9C, a basic sketch illustrating a frame element that can be placedin a sealed fashion against a further mask structure according to anembodiment of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS

A portion of a simplified breathing mask device is shown in FIG. 1 andincludes a body structure or mask frame 1 and a sealing lip device 2coupled with the body structure. By means of the body structure 1 andthe sealing lip device 2, a breathing mask interior I is sealed off fromthe environment U, in cooperation with a user's face area G, shown hereonly schematically and not exactly to scale.

The breathing mask device shown here is distinguished by the fact that agel structure 3 is provided, and the gel material 4 that forms this gelstructure is received in an elastically deformable receiving wall 5 orjacket. This receiving wall 5 is made by integrally forming theelastomer material, provided for forming the receiving wall 5, onto awall portion 1 a, and this material is lifted or separated from the wallportion 1 a for forming the gel receiving chamber GA that receives thegel material 4.

The gel receiving chamber GA forms a bracing bead portion that bracesthe breathing mask device on the area G of the user's face on which itrests. The bracing bead portion extends between the body structure 1 anda highly elastic, preferably relatively thin-walled user's face sealinglip 2 b of the sealing lip device 2, and in the application position ofthe mask can be seated on the inside of the user's face sealing lip 2 b,or optionally on the area of the user's face it is intended to rest on.

The user's face sealing lip 2 b and the receiving wall portion 5 that inportions defines the gel receiving chamber GA are thus embodiedintegrally to this extent.

The body structure 1 is preferably embodied as a hard mask shell made ofa fully transparent thermoplastic plastic material. It includesconnection structures, not shown further here, for connecting breathinggas lines or valve devices.

The sealing lip device 2 is injection-molded onto this hard mask shell,as will be described in further detail hereinafter. In the state shownhere in FIG. 1, the sealing lip device 2 is seated on adhesion zones 7,8, 9, thus making a heavy-duty adhesive bond, which are formed by coronaor plasma treatment of the hard mask shell. The wall portion 1 a of thehard mask shell forms a detachment zone from which the material intendedfor forming the receiving wall 5 is lifted or separated from the wallportion 1 a.

The production of the breathing mask device shown here can be done asdescribed hereinafter.

In FIG. 2A, a multi-piece molding tool is furnished, which in a firstmold closing state furnishes a mold chamber intended to form the bodystructure 1 or the hard mask shell. This multi-part molding tool isshown here broken down merely as an example into mold segments A, B, C.Once the preferably thermoplastic plastic material intended for formingthe hard shell has been injected into the mold chamber of the moldingtool, and the plastic material has hardened sufficiently, the moldingtool is opened by removing the core segment C. Next, preferably using acovering mask, adhesion zones 10, 11, 12 are embodied on the bodystructure 1 by corona or plasma treatment or some other kind of reactivetreatment of the hard mask shell that otherwise still remains in themolding tool. In FIGS. 2B-1 to 2B-3, these adhesion zones 10, 11, 12 areshown in further detail.

Next, instead of the mold segment C, a core segment C′ and/or C″, whichis preferably again in multiple parts, is inserted into the molding toolas shown in FIG. 3. By means of this mold segment, a mold chamberintended for forming the sealing lip device 2 is furnished. An elastomermaterial, preferably liquid silicone rubber (LSR), is now injected intothis mold chamber. This silicone material now enters into a firmlyadhesive bond with the material of the hard mask shell, in the zones 10,11, 12 sketched in FIGS. 2A and 2B-1 to 2B-3. In the wall portion 1 a ofthe hard shell 1 adjacent to the wall 5, the silicone material is merelyadjacent to or in contact with the wall portion 1 a, but the siliconematerial is not bonded or is only slightly bonded to the wall portion 1a. The breathing mask device thus formed and including the bodystructure 1 or hard shell element and the sealing lip device 2injection-molded onto it can be removed from the molding tool bysuitable opening of the molding tool. By forcing a viscous medium,especially of silicone gel, into the boundary region defined between thereceiving wall 5 and the hard shell 1, it becomes possible to lift thereceiving wall 5 gradually from the body structure 1 and in the processgradually to form the gel structure 3 (see FIG. 1).

As can be seen from FIG. 4, it is possible to provide a filling stubstructure 13 on the hard shell 1, through which the gel material canadvantageously be introduced. Introducing the gel material and thedetachability of the elastomer material injection-molded onto the hardshell in the region of the wall portion 1 a can be reinforced by specialsurface properties in the region of the wall portion 1 a and inparticular also by means of flat preferential conduit geometries. Thefilling stub structure 13 can be embodied in such a way that it isadvantageously closable, in particular in automated fashion. The closingcan be done in particular by means of a screw, plug or peg structure.

FIG. 5 sketches a concept by which an “enlarged wall portion” la iscreated on the hard shell 1 or body structure, specifically by designingthe cross section of the body structure 1 such that it has a strutlikeor wavy form. The wall initially injection-molded onto the wall portion1 a here can then be lifted from this wall portion 1 a, and in thecorresponding cross section has essentially the same developed area, orlength/width, as the length/width of the supporting wall 1 a.

FIG. 6 shows a cross-sectional sketch in which the wall 5injection-molded onto the wall portion 1 a has different wallthicknesses. Adapting these wall thicknesses makes it possible to exertinfluence on the mechanical properties of the gel structure that isfinally to be formed in cooperation with the wall 5. The mechanicalproperties of the sealing lip device 2 a resting on the area G of auser's face can also be defined by special designing of the course ofthe wall thickness and of the profiling of the sealing lip device.

As shown in sketchlike form in FIG. 7A, an embodiment of the inventionfor forming a gel receiving chamber GA can be realized especiallyadvantageously by making a rigid/elastomer pairing of materials.Reactive zones 10, 11 are embodied on the rigid structure 1. Theelastomer material is initially injection-molded over the full area ofthe rigid structure 1 and in the process forms the wall 5 contacting thewall portion 1 a. By introduction into the boundary region between thewall 5 and the supporting portion 1 a, it becomes possible to inflatethe wall 5 into the state represented here by dashed lines and as aresult to create a gel-reinforced bead.

In FIG. 7B, a variant is shown in sketchlike form in which an embodimentof the invention is realized with a pairing of soft/soft orelastomer/elastomer materials. A second elastomer layer 5′ isinjection-molded onto the structure 1′, here embodied of an elastomermaterial. Before the second injection step, intended for forming thewall 5′, is performed, the structure 1′ is pretreated in such a way thatit includes reactive zones 10′, 11′. By introducing a viscous medium, inparticular silicone gel, into the gap region formed between the wallportions 1′, 5′, it becomes possible to create the inflated cushioningstructure represented here by dashed lines.

FIG. 8 in sketchlike form shows a breathing mask device according toanother variant. This breathing mask device includes the body structure1, which is embodied here as a completely transparent hard shell. Thebody structure 1 forms a connection opening 100 for connecting a linedevice serving to deliver breathing gas.

A sealing lip device 2 is injection-molded onto the body structure 1.The sealing lip device 2 is embodied such that it includes a bridgeportion 2 e, crossing the bridge of a user's nose, side portions 2 f, 2g, and a lower bridge portion 2 h crossing the upper lip or the chinregion of the user. In the regions 2 f, 2 g, the sealing lip device 2has a cross section that is approximately equivalent to the makeup shownin FIG. 1. In the region of the bridge portion 2 e, the breathing maskdevice shown here has no gel structure. In the regions 2 f and 2 g, twobeadlike gel cushions GP are provided, extending in beadlike form and,in the application position, along the side surface of the nose. Thesegel cushions GP are bounded partly by the body structure 1 and partly bythe wall 5 that points toward the sealing lip 2 b (see FIG. 1) and havea three-dimensionally greatly curved, finger-like course.

In FIG. 9A, a variant is illustrated by which it becomes possible tofurnish an enlarged injection-molding surface 1 a for the embodiment ofthe wall 5. This is achieved by embodying a strut 111 on the structuralcomponent 1. This strut, after the detachment of the wall 5 from thestrut 111, dips into the gel receiving chamber GA. The strut 111 candamp the shifting of gel material in the gel receiving chamber and canthus influence the mechanical properties of the gel cushion. The strut111 may be embodied to function as an end stop and prevents excessivedeformation of the gel cushion. The definition of the region of theelastomer material, which serves as a gel chamber wall, is attained inthis variant as well by embodying reactive zones 10, 11, on theinjection-molding contact face toward the structure 1, which zonesassure a sufficiently strong adhesion of the gel material to thestructural part 1.

FIG. 9B shows a gel cushion of a breathing mask according to anembodiment of the present invention. This gel cushion may extend all theway around the entire circumference of the sealing lip, or it may beprovided as gel segments in only some portions. Such gel segmentspreferably extend within the portion of the sealing lip device that isprovided for resting on the cheek region. The gel material may beviscous, or in other words fluid, or partly crosslinked, or in otherwords may be very resilient. Other kinds of filling materials can alsobe introduced into the receiving chamber GA. These materials arepreferably colored such that they lend the mask an aestheticallyappealing external appearance.

FIG. 9C shows an embodiment of the invention that can be realized incombination with a frame element 11′. By using the elastomer material,sealing structures, e.g., saw tooth region 11′, can also be made, whichserve to seal off and optionally secure the thus-created sealingstructure to a mask body or other kind of carrier system.

While the invention has been described in connection with what arepresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the invention. Also, the various embodiments described abovemay be implemented in conjunction with other embodiments, e.g., aspectsof one embodiment may be combined with aspects of another embodiment torealize yet other embodiments. Alternatively, further embodiments mayinclude a single component or subportion thereof of any givenembodiment. In addition, while the invention has particular applicationto patients who suffer from OSA, it is to be appreciated that patientswho suffer from other illnesses (e.g., congestive heart failure,diabetes, morbid obesity, stroke, barriatric surgery, etc.) can derivebenefit from the above teachings. Moreover, the above teachings haveapplicability with patients and non-patients alike in non-medicalapplications.

1. A mask to administer breathable gas to a user, the mask comprising: abody structure having a connection opening to connect to a line deviceto deliver the breathable gas; a sealing lip device to seal against theuser's face, the sealing lip device joined to the body structure, andthe sealing lip device having an upper bridge portion structured tocross the bridge of the user's nose in use, a pair of side portionsstructured to be positioned along corresponding side surfaces of theuser's nose in use, and a lower bridge portion structured to cross theuser's upper lip or chin region in use; and a pair of beadlike gelcushions, each positioned in a corresponding one of the side portions.2. The mask of claim 1, wherein the body structure further comprises atransparent, hard shell.
 3. The mask of claim 1, wherein the sealing lipdevice is injection-molded onto the body structure.
 4. The mask of claim1, wherein the upper bridge portion does not include any gel structure.5. The mask of claim 1, wherein the pair of beadlike gel cushions arebounded partly by the body structure and partly by the sealing lipdevice.
 6. The mask of claim 1, wherein the pair of beadlike gelcushions are curved.
 7. The mask of claim 1, further comprising afull-face mask or a nasal mask.
 8. A breathing mask device foradministering a breathable gas, the breathing mask device comprising: abody structure having a connection opening to connect to a line deviceto deliver the breathable gas; a sealing lip device joined to the bodystructure; a breathing mask interior defined at least in part by thebody structure and the sealing lip device; a gel structure configured toat least intermittently and partially transmit retention forces actingon the body structure to the user's face area; and a gel materialdefining the gel structure received in a gel receiving chamber definedat least in part by an elastically deformable receiving wall, whereinthe gel receiving chamber further comprises a bracing bead portion, andwherein the bracing bead portion extends between the body structure ofthe breathing mask device and the sealing lip device of the breathingmask device.
 9. The breathing mask device of claim 8, wherein thebracing bead portion extends over the entire circumference of thesealing lip device.
 10. The breathing mask device of claim 8, whereinthe bracing bead portion is segmented, such that the bracing beadportion extends only in a contact region of the sealing lip device thatlaterally borders the user's nose.
 11. The breathing mask device ofclaim 8, wherein in the region of the sealing lip device that crossesthe bridge of the nose as well as the upper lip region or the chinregion there is no gel structure.
 12. The breathing mask device of claim8, wherein the gel structure is recessed, such that the gel structuretransmits no bracing forces in a region of the bridge of the nose andthe upper lip or the chin.
 13. The breathing mask device of claim 8,wherein the body structure comprises a hard mask shell or frame element.14. The breathing mask device of claim 8, further comprising a fillingconduit structure provided on the body structure.
 15. The breathing maskdevice of claim 8, further comprising a full-face mask or a nasal mask.16. The breathing mask device of claim 8, an elastomer material of theelastically deformable receiving wall is integrally formed onto the bodystructure of the breathing mask device.
 17. The breathing mask device ofclaim 16, wherein the elastically deformable receiving wall is lifted orseparable from the body structure to form the gel receiving chamber. 18.The breathing mask device of claim 8, wherein the sealing lip device isinjection-molded onto the body structure.
 19. The breathing mask deviceof claim 18, wherein before injection molding of the sealing lip,adhesion zones are generated on the body structure.
 20. The breathingmask device of claim 19, wherein the adhesion zones are generated bycorona or plasma treatment.